Sterile drapes are used during medical procedures to maintain a sterile field which can be used by the medical operator during a medical procedure to prevent contamination of the site upon or through which the operator performs the procedure. The drape maintains an effective barrier that minimizes or prevents the passage of microorganisms between the sterile and non-sterile fields. The drape should be resistant to blood and aqueous fluid. Sterile drapes are generally made of a water repellent or water-impermeable material, or are coated with such a material. Sterile drapes commonly contain one or more openings (fenestrations) through which the procedure is performed. The drapes commonly used during angiography and cardiac catheterization procedures include access site fenestrations to allow access to the left or right femoral arteries. These fenestration sites can be situated over the femoral arteries, and then affixed to the skin along the outer edges of the fenestrations to secure and maintain the position of the drape relative to the access site during the procedure.
Cardiac catheterization and angiography procedures are medical procedures which are generally performed from femoral (groin) access sites, and more recently from radial (wrist) artery access sites. A sterile drape is situated with the appropriate fenestration site secured over the chosen arterial access site. An arterial access sheath is introduced through the fenestration into the appropriate artery. The sheath then permits introduction of arterial catheters or tubes, which in turn allows introduction of X-ray contrast dye and equipment through catheters to the organ being investigated or treated.
Four common options for cardiac catheterization angiography access sites (arterial catheterization) are currently available and may be selected depending upon the individual patient, medical procedure to be performed, and preference of the operator. Access through the right femoral artery is the most commonly used and catheter designs are geared for this approach. Access through the left femoral artery may be used if the right femoral artery is not available. The third is right radial artery access. This approach is becoming more popular because of a significant decrease in vascular risk to the patient from this approach. However, access through the right radial artery is more time consuming and technically challenging for the operator. The fourth, and least common approach, is through the left radial artery.
The radial approach has been gaining popularity over the past 10-20 years because of potential advantages in patient comfort, procedural costs, procedural complications, major and minor complications, and length of stay. Relative to the femoral approach, a radial artery catheterization strategy has been estimated to reduce major bleeding from 6.1% to 2.7% of catheterization procedures and to reduce major vascular complications from 0.45% to 0.16% of catheterization procedures. However, once a sterile drape is applied 2-5% of procedures attempted from the radial approach cannot be completed in this manner, necessitating a switch in the preparation by the staff, in mid procedure, from draping the radial arterial area to the femoral arterial area, which lengthens procedural time.
Despite the continued growth in radial artery procedures performed, no single approach is universally adopted in any center or by any single cardiologist. Therefore, any technical improvements in catheterization pre-procedural set-up which assist in a more universal approach could save time, could improve profitability, and could reduce procedural complications.
During a medical procedure, it may be the case that the arms of a patient may move thus potentially causing the surgical drape to move out of position thus jeopardizing the sterile field. Further, the arms of the patient may not be in a comfortable or convenient position for the patient or for the health care provider during use of the surgical drape. As such, there remains room for variation and improvement within the art.
Repeat use of reference characters in the present specification and drawings is intended to represent the same or analogous features or elements of the invention.